Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - rukobia

Document Subject

Generated Narrative: MedicinalProductDefinition mp4ebd45ede513ed024b967ea8c9e55dab

identifier: http://ema.europa.eu/identifier/EU/1/20/1518/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Rukobia 600 mg prolonged-release tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-4ebd45ede513ed024b967ea8c9e55dab

identifier: http://ema.europa.eu/identifier/EU/1/20/1518/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - rukobia

Attesters

What is in this leaflet

1. What Rukobia is and what it is used for
2. What you need to know before you take Rukobia
3. How to take Rukobia
4. Possible side effects
5. How to store Rukobia
6. Contents of the pack and other information

Rukobia contains fostemsavir and is a type of HIV medicine (anti-retroviral) known as an attachment inhibitor (AI). It works by attaching to the virus and then blocking it from entering your blood cells.

Rukobia is used with other anti-retroviral medicines (combination therapy), to treat HIV infection in adults with limited treatment options (other anti-retroviral medicines are not sufficiently effective or are not suitable).

Rukobia does not cure HIV infection; it reduces the amount of virus in your body and keeps it at a low level. Given HIV reduces the number of CD4 cells in your body, keeping HIV at a low level also increases the CD4 cell count in your blood. CD4 cells are a type of white blood cell that are important in helping your body fight infection.

Do not take Rukobia

• if you are allergic to fostemsavir or to any of the other ingredients of this medicine (listed in Section 6)
• if you are taking any of these medicines: * carbamazepine, or phenytoin (used to treat epilepsy and prevent seizures (fits)) * mitotane (to treat several types of cancer) * enzalutamide (to treat prostate cancer) * rifampicin (to treat some bacterial infections such as tuberculosis) * medicines that contain St John s wort (Hypericum perforatum) (a herbal product for depression). If you think any of these apply to you, do not take Rukobia until you have checked with your doctor.

Warnings and precautions
Conditions you need to look out for
Some people taking medicines for HIV infection develop other conditions, which can be serious. These include:

infections and inflammation joint pain, stiffness and bone problems You need to know about important signs and symptoms to look out for while you are taking Rukobia.
See Section 4 of this leaflet.

Before you take Rukobia your doctor needs to know

• if you have or had a heart problem, or if you notice any unusual changes in your heart beat (such as beating too fast or too slow). Rukobia can affect heart rhythm.
• if you have or had liver disease, including hepatitis B or hepatitis C.
  Talk to your doctor if this applies to you. You may need extra check-ups, including blood tests, while you are taking your medicines.

You will need regular blood tests For as long as you are taking Rukobia, your doctor will arrange regular blood tests to measure the amount of HIV in your blood, and to check for side effects. There is more information about these side effects in Section 4 of this leaflet.

Stay in regular contact with your doctor Rukobia helps to control your condition, but it is not a cure for HIV infection. You need to keep taking it every day to stop your illness from getting worse. Because Rukobia does not cure HIV infection, you may still develop other infections and illnesses linked to HIV infection. Keep in touch with your doctor, and do not stop taking Rukobia without your doctor s advice.

Children and adolescents Rukobia is not recommended for people aged under 18 years because it has not been studied in this age group.

Other medicines and Rukobia
Tell your doctor or pharmacist if you are taking any other medicines, if you have taken any recently, or if you start taking new ones.

Rukobia must not be taken with some other medicines

Do not take Rukobia if you are taking any of these medicines:

• carbamazepine, or phenytoin, to treat epilepsy and prevent seizures

• mitotane, to treat several types of cancer

• enzalutamide, to treat prostate cancer

• rifampicin, to treat some bacterial infections such as tuberculosis

• products that contain St John s wort (Hypericum perforatum) (an herbal product for depression). This medicine is not recommended with Rukobia:

  elbasvir/grazoprevir, to treat hepatitis C infection.

  Tell your doctor or pharmacist if you are being treated with this medicine.

Some medicines can affect how Rukobia works

Or they can make it more likely that you will have side effects. Rukobia can also affect how some other medicines work. Tell your doctor if you are taking any of the medicines in the following list:

• amiodarone, disopyramide, ibutilide, procainamide, quinidine, or sotalol, used to treat heart conditions
• statins (atorvastatin, fluvastatin, pitavastatin, rosuvastatin or simvastatin), used to lower cholesterol levels
• ethinyl estradiol, used for birth control
• tenofovir alafenamide, used as an antiviral. Tell your doctor or pharmacist if you are taking any of these. Your doctor may decide to adjust your dose or that you need extra check-ups.

Pregnancy
If you are pregnant, or think you could be, or if you are planning to have a baby, do not take Rukobia without checking with your doctor. Your doctor will discuss with you the benefit and the risk to your baby of taking Rukobia while you re pregnant.

Breast-feeding Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk.

It is not known whether the ingredients of Rukobia can pass into breast milk and harm your baby. If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible.

Driving and using machines
Rukobia can make you dizzy and have other side effects that make you less alert. Do not drive or use machines unless you are sure you are not affected.

Always take Rukobia exactly as your doctor has told you to. Check with your doctor or pharmacist if you are not sure.

• The usual dose of Rukobia is one 600 mg tablet, twice a day.

• Rukobia should be swallowed whole, with some liquid. Do not chew, crush or split the tablets if you do, there is a danger the medicine may be released into your body too quickly.

• You can take Rukobia with or without food.

If you take more Rukobia than you should
If you take too many tablets of Rukobia contact your doctor or pharmacist. If possible, show them the Rukobia pack.

If you forget to take Rukobia
Take it as soon as you remember. However, if it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take a double dose to make up for a missed dose. If you are not sure what to do, ask your doctor or pharmacist.

If you stop taking Rukobia Do not stop Rukobia without checking with your doctor.
To control your HIV infection and to stop your illness getting worse, take Rukobia for as long as your doctor recommends. Do not stop unless your doctor asks you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, but not everybody gets them, so it is very important to talk to your doctor about any changes in your health.

Symptoms of infection and inflammation are common (may affect up to 1 in 10 people)
People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to develop serious infections (opportunistic infections). When they start treatment, the immune system becomes stronger, so the body starts to fight infections. Symptoms of infection and inflammation may develop, caused by either: old, hidden infections flaring up again as the body fights them
the immune system mistakenly attacking healthy body tissue (autoimmune disorders).

The symptoms of autoimmune disorders may develop many months after you start taking medicine to treat your HIV infection.

Symptoms may include: muscle weakness and/or pain joint pain or swelling weakness that starts in the hands and feet and moves up towards the trunk of the body palpitations or tremor excessive restlessness and movement (hyperactivity).

If you get any symptoms of infection and inflammation or if you notice any of the symptoms above: Tell your doctor immediately. Do not take other medicines for the infection without checking with your doctor. Very common side effects (may affect more than 1 in 10 people):

• feeling sick (nausea)
• diarrhoea
• being sick (vomiting)
• stomach pain (abdominal pain)
• headache
• rash. Talk to your doctor if you get any side effects.

Common side effects (may affect up to 1 in 10 people):

• indigestion (dyspepsia)
• lack of energy (fatigue)
• disturbance in heart rhythm seen in ECG test (prolonged QT interval)
• muscle pain (myalgia)
• feeling drowsy (somnolence)
• dizziness
• taste disturbance (dysgeusia)
• wind
• difficulty sleeping (insomnia)
• itching (pruritus). Talk to your doctor if you get any side effects.

Some side effects may only be seen in your blood tests and may not appear immediately after you start taking Rukobia.

Common side effects that may show up in blood tests are:

• increase in enzymes produced in the muscles (creatine phosphokinase, an indicator of muscle damage)
• increase in creatinine, an indicator of how well your kidneys are working
• increase in enzymes produced in the liver (transaminases, an indicator of liver damage).

Other side effects that may show up in blood tests
Other side effects have occurred in some people but their exact frequency is unknown:

• increase in bilirubin (a substance produced by the liver) in the blood.

Joint pain, stiffness and bone problems Some people taking combination therapy for HIV develop a condition called osteonecrosis. With this condition, parts of the bone tissue die because of reduced blood supply to the bone. People may be more likely to get this condition: if they have been taking combination therapy for a long time if they are also taking anti-inflammatory medicines called corticosteroids if they drink alcohol if their immune systems are very weak if they are overweight. Signs of osteonecrosis include: stiffness in the joints aches and pains in the joints (especially in the hip, knee or shoulder) difficulty moving.

If you notice any of these symptoms:

Tell your doctor.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

Keep out of the sight and reach of children.

Do not take Rukobia after the expiry date shown on the pack which is stated after EXP on the carton and bottle.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines in wastewater or household waste. Ask your pharmacist how to throw away medicines no longer required. This will help protect the environment.

What Rukobia contains
The active substance is fostemsavir. Each tablet contains fostemsavir tromethamine equivalent to 600 mg fostemsavir.
The other ingredients are hydroxypropylcellulose, hypromellose, colloidal anhydrous silica, magnesium stearate, poly(vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172), iron oxide red (E172).

What Rukobia looks like and contents of the pack Rukobia 600 mg prolonged-release tablets are beige, oval, biconvex tablets, approximately 19 mm in length, 10 mm in width, and 8 mm in thickness, film-coated, and marked with the code SV 1V7 on one side.

Each pack consists of one or three bottles, each containing 60 prolonged-release tablets.

Not all pack sizes may be available in your country.

Marketing Authorisation Holder ViiV Healthcare BV Van Asch van Wijckstraat 55H 3811 LP Amersfoort Netherlands

Manufacturer GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana, San Polo di Torrile Parma, 43Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien ViiV Healthcare srl/bv
T l/Tel: + 32 (0) 10 85 65 Lietuva ViiV Healthcare BV Tel: + 370 80000
ViiV Healthcare BV Te .: + 359 80018Luxembourg/Luxemburg ViiV Healthcare srl/bv
Belgique/Belgien T l/Tel: + 32 (0) 10 85 65 esk republika GlaxoSmithKline, s.r.o. Tel: + 420 222 001 cz.info@gsk.com

Magyarorsz g ViiV Healthcare BV Tel: + 36 80088Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 dk-info@gsk.com

Malta ViiV Healthcare BV Tel: + 356 80065Deutschland ViiV Healthcare GmbH
Tel.: + 49 (0)89 203 0038-viiv.med.info@viivhealthcare.com

Nederland ViiV Healthcare BV
Tel: + 31 (0)33 2081Eesti ViiV Healthcare BV Tel: + 372 8002Norge GlaxoSmithKline AS Tlf: + 47 22 70 20
GlaxoSmithKline A.E.B.E. : + 30 210 68 82 sterreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 at.info@gsk.com

Espa a Laboratorios ViiV Healthcare, S.L.
Tel: + 34 900 923 es-ci@viivhealthcare.com

Polska GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9France ViiV Healthcare SAS
T l.: + 33 (0)1 39 17 69 Infomed@viivhealthcare.com Portugal VIIVHIV HEALTHCARE, UNIPESSOAL, LDA
Tel: + 351 21 094 08 viiv.fi.pt@viivhealthcare.com

Hrvatska ViiV Healthcare BV Tel: + 385 800787Rom nia ViiV Healthcare BV Tel: + 40800672Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955Slovenija ViiV Healthcare BV Tel: + 386 80688 sland Vistor hf. S mi: +354 535 7Slovensk republika ViiV Healthcare BV Tel: + 421 800500Italia ViiV Healthcare S.r.l
Tel: + 39 (0)45 7741Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 Finland.tuoteinfo@gsk.com

ViiV Healthcare BV : + 357 80070Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 info.produkt@gsk.com

Latvija ViiV Healthcare BV Tel: + 371 80205United Kingdom (Northern Ireland) ViiV Healthcare BV Tel: + 44 (0)800 221customercontactuk@gsk.com

This leaflet was last revised in {MM/YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: